Pivekimab Sunirine

Extended indication	Pivekimab sunirine monotherapy for second line or later treatment of relapsed or refractory CD123-positive Blastic plasmacytoid dendritic cell neoplasia in adults and elderly
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	Pivekimab Sunirine
Domain	Hematology
Reason of inclusion	New medicine (specialité)
Main indication	Myeloproliferative disorders
Extended indication	Pivekimab sunirine monotherapy for second line or later treatment of relapsed or refractory CD123-positive Blastic plasmacytoid dendritic cell neoplasia in adults and elderly
Manufacturer	Abbvie
Portfolio holder	Abbvie
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)
Additional remarks	Pivekimab Sunirine is an antibody-drug conjugate (ADC) comprising a high-affinity CD123 antibody, cleavable linker, and an indolinobenzodiazepine pseudodimer (IGN) payload. The IGN payload alkylates DNA and causes single strand breaks without crosslinking. IGNs are designed to have high potency against tumor cells, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads.

Registration route	Centralised (EMA)
ATMP	No
Submission date	March 2025
Expected Registration	April 2026
Orphan drug	Yes
Registration phase	Clinical trials
Additional remarks	Indieningsdatum gebaseerd op de primary completion datum in december 2024.

Therapeutic value	No estimate possible yet
References	NCT03386513

There is currently nothing known about the expected patient volume.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.